Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar MYL-1601D with US and European insulin aspart in healthy volunteers: A randomized, double-blind, crossover, euglycaemic glucose clamp study

Autor:	Ulrike, Hövelmann, Yaron, Raiter, Anoop, Chullikana, Mark, Liu, Charles, Donnelly, Tracey, Lawrence, Nilanjan, Sengupta, Gopu, Cl, Gopinath, Ranganna, Abhijit, Barve
Rok vydání:	2021
Předmět:	Cross-Over Studies Glucose Double-Blind Method Therapeutic Equivalency Area Under Curve Glucose Clamp Technique Humans Hypoglycemic Agents Biosimilar Pharmaceuticals Healthy Volunteers Insulin Aspart
Zdroj:	Diabetes, obesitymetabolism. 23(12)
ISSN:	1463-1326
Popis:	To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence (BE) of MYL-1601D biosimilar with originator, NovoLog (Ref-InsAsp-US), and NovoRapid (Ref-InsAsp-EU).This was a double-blind, randomized, crossover study that enrolled 71 healthy subjects to receive a single subcutaneous dose (0.2 U/kg) of each formulation under automated euglycaemic clamp conditions (ClampArt, level 81 mg/dL, duration 12 hours postdose). Primary PK endpoints were area under the plasma insulin aspart concentration-time curve from 0 to 12 hours (AUCMYL-1601D showed PK BE to both Ref-InsAsp-US (AUCMYL-1601D showed BE to Ref-InsAsp-US and Ref-InsAsp-EU with a comparable safety profile.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=pmid________::ccf59c2fe170fefc85f32dd839f9006b https://pubmed.ncbi.nlm.nih.gov/34378861 Zobrazit plný text záznamu Plný text